Coronary Artery Disease (CAD)NCT07596992
Effects of Royal Jelly and Propolis on Metabolomic Signatures, Inflammation, and Cardiovascular Risk in Patients With Coronary Artery Disease.
A study testing Propolis + Royal Jelly in people with Coronary Artery Disease (CAD) and Oxidative Stress, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The aim of this project is to evaluate the effect of bioactive compound sources, propolis and royal jelly, on metabolomics, inflammation, and cardiovascular risk markers in participants with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Oxidative Stress, Inflammation
- What is being tested?
- Propolis + Royal Jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 18 May 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes
- Over 18 years of age;
- Diagnosed with Coronary Artery Disease: confirmed by coronary angiography, coronary computed tomography angiography, or functional testing with ischemic load);
- Participants who are asymptomatic or have angina limited to functional class III will be considered;
- Patients who have already undergone coronary revascularization and angioplasty may participate;
- the last acute coronary event must have occurred more than one year ago.
Who cannot join
- Unstable Coronary Artery Disease;
- Pre-operative coronary artery bypass grafting or awaiting elective angioplasty;
- Unstable angina;
- NYHA functional class III or higher;
- Advanced chronic kidney disease (creatinine clearance < 30 ml/min/1.73 m²);
- Individuals with autoimmune diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Denise mafra
Niterói, Rio de Janeiro, 24220-900
Ludmila Cardozo, +5521987333185, ludmilacardozo@id.uff.br
About this study
The aim of this project is to evaluate the effect of bioactive compound sources, propolis and royal jelly, on metabolomics, inflammation, and cardiovascular risk markers in participants with coronary artery disease. A longitudinal double-blind randomized clinical trial will be carried out, involving CAD participants for two months.
Read the detailed description
Several sources of bioactive compounds have been studied due to their protective effect against coronary artery disease (CAD), mainly by modulating inflammation and oxidative stress. Among them, propolis stands out, rich in flavonoids and phenolic acids, which exhibits antioxidant and anti-inflammatory activity; and royal jelly, containing bioactive peptides that promote endothelial function and have an anti-inflammatory effect, potentially contributing to the prevention of CAD progression. Regular consumption of these foods may represent a complementary therapeutic strategy for CAD prevention.
- Being tested
- Propolis + Royal Jelly, Placebo
- Keywords
- royal jelly, propolis, coronary artery disease, oxidative stress, inflammation
- Medical subject headings
- Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis + Royal JellyDietary supplement
They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.
PlaceboDietary supplement
They will receive 4 capsules per day, providing daily delivery of the active formulation vehicle (microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal contents).
| Study group | Role | What they receive |
|---|---|---|
| Propolis + Royal jelly Group | Experimental | They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day. Receives: Dietary Supplement: Propolis + Royal Jelly |
| Placebo Group | Placebo comparator | They will receive 4 capsules per day, providing daily delivery of the active formulation vehicle (microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal contents). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of inflammatory status in the participants
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start18 May 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Sponsor
- Investigators
- Ludmila Cardozo, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596992
- Sponsor's protocol ID
- Denise Mafra_DAC2
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be public to other research unless necessary.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Royal Jelly and Propolis on Metabolomic Signatures, Inflammation, and Cardiovascular Risk in Patients With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT07596992
- Acronym / sponsor ID
- Denise Mafra_DAC2
- Keywords
- royal jelly, propolis, coronary artery disease, oxidative stress, inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- 18 May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to evaluate the effect of bioactive compound sources, propolis and royal jelly, on metabolomics, inflammation, and cardiovascular risk markers in participants with coronary artery disease. A longitudinal double-blind randomized clinical trial will be carried out, involving CAD participants for two months.
Detailed description
Several sources of bioactive compounds have been studied due to their protective effect against coronary artery disease (CAD), mainly by modulating inflammation and oxidative stress. Among them, propolis stands out, rich in flavonoids and phenolic acids, which exhibits antioxidant and anti-inflammatory activity; and royal jelly, containing bioactive peptides that promote endothelial function and have an anti-inflammatory effect, potentially contributing to the prevention of CAD progression. Regular consumption of these foods may represent a complementary therapeutic strategy for CAD prevention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis + Royal jelly Group | Experimental | Dietary Supplement: Propolis + Royal JellyThey will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboThey will receive 4 capsules per day, providing daily delivery of the active formulation vehicle (microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal contents). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both sexes
- Over 18 years of age;
- Diagnosed with Coronary Artery Disease: confirmed by coronary angiography, coronary computed tomography angiography, or functional testing with ischemic load);
- Participants who are asymptomatic or have angina limited to functional class III will be considered;
- Patients who have already undergone coronary revascularization and angioplasty may participate;
Key exclusion criteria (6 listed)
- Unstable Coronary Artery Disease;
- Pre-operative coronary artery bypass grafting or awaiting elective angioplasty;
- Unstable angina;
- NYHA functional class III or higher;
- Advanced chronic kidney disease (creatinine clearance < 30 ml/min/1.73 m²);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propolis + Royal JellyThey will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day. | Dietary supplement | Propolis + Royal jelly Group |
| PlaceboThey will receive 4 capsules per day, providing daily delivery of the active formulation vehicle (microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal contents). | Dietary supplement | Placebo Group |
Primary outcome
Change of inflammatory status in the participants
Time frame: Baseline and 8 weeks
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Participant data will not be public to other research unless necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ludmila Cardozo principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis + Royal Jelly in people with Coronary Artery Disease (CAD) and Oxidative Stress, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Mafra (+5521985683003, dmafra30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of inflammatory status in the participants (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.